The bottle cap can be cracked which can cause the child-resistant closure to be ineffective
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Merck Sharp & Dohme of Whitehouse Station, N.J., is recalling about 276,000 bottles with cracked caps containing Temodar (Temozolomide) and Temozolomide (generic) capsules
The cracked bottle can cause the child-resistant closure to be ineffective, allowing young children to gain unintended access to the capsules, posing a risk of poisoning.
No incidents or injuries have been reported.
This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsules, an oral chemotherapy drug. The capsules were distributed in 5- and 14-count brown glass bottles that have white plastic child-resistant caps. A white label affixed to the bottle has the word “Temozolomide” printed in black lettering.
The medication, manufactured in the U.S., was sold at clinics and pharmacies nationwide as a prescribed medicine from July 2013, to August 2015. The container was included in the cost of the medication which is based on quantities prescribed, health insurance terms and other factors.
Consumers should immediately inspect their bottle caps for cracks. If a crack is found, consumers should contact Merck for a replacement cap. As with all drug products, the bottles should be stored up high, out of sight and reach of young children. Consumers may continue to use the drug as directed.
Consumers may contact the Merck information center at 800-943-8069 from 8 a.m. to 8 p.m. (ET) Monday through Friday, or visit www.merck.com and click on “Important Temodar Information” for more information.
